CN108430546B - 用于流体输送的具有减小的死区的医疗装置 - Google Patents

用于流体输送的具有减小的死区的医疗装置 Download PDF

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CN108430546B
CN108430546B CN201680072022.6A CN201680072022A CN108430546B CN 108430546 B CN108430546 B CN 108430546B CN 201680072022 A CN201680072022 A CN 201680072022A CN 108430546 B CN108430546 B CN 108430546B
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CN108430546A (zh
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O·卡比里
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Western Medicine Services Israel Branch
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Abstract

本文公开了一种药物注射筒,其具有带近侧开口的圆筒形膛,注射筒包括膛的远侧壁,所述远侧壁限定从注射筒的中心轴线偏置的出口,并朝向远侧壁的第一区域并且从中心轴线远离与第一区域不同的第二区域偏置;该注射筒包括具有远侧表面的柱塞密封件;其中当所述柱塞密封件被装配到膛中时,远侧表面面向所述膛的所述远侧壁的内表面,内表面的第二区域在平行于圆筒形膛的中心轴线的方向比所述第一区域在轴向上更靠近柱塞密封件的远侧表面,使得流体从第二区域朝向出口排出。

Description

用于流体输送的具有减小的死区的医疗装置
技术领域
本发明在其一些实施例中涉及成角度的注射筒,并且更具体地但非排他地涉及具有减小的流体死区的成角度的注射筒。
背景技术
专利号为6500150的美国专利公开了“一种药物输送装置,其具有限定皮肤接触表面的基座构件、用作药物储存器的注射筒以及用于将药物从注射筒排出的装置。注射筒连接到基座构件,使得注射筒的纵向轴线大致平行于皮肤表面。输送针与注射筒连通。针具有成角度的弯曲,其引导针的尖端基本上垂直于皮肤接触表面。在使用中,针的尖端适于穿透对象的皮肤”。
专利号为6824529的美国专利公开了“一种药物输送装置,其具有限定皮肤接触表面的基座构件、用作药物储存器的注射筒以及用于将药物从注射筒排出的装置。注射筒连接到基座构件,使得注射筒的纵向轴线大致平行于皮肤表面。输送针与注射筒连通。针具有成角度的弯曲,其引导针的尖端基本上垂直于皮肤接触表面。在使用中,针的尖端适于穿透对象的皮肤”。
专利号为6843782的美国专利公开了“一种药物输送装置,其具有限定皮肤接触表面的基座构件、用作药物储存器的注射筒以及用于将药物从注射筒排出的装置。注射筒连接到基座构件,使得注射筒的纵向轴线大致平行于皮肤表面。输送针与注射筒连通。针具有成角度的弯曲,其引导针的尖端基本上垂直于皮肤接触表面。在使用中,针的尖端适于穿透对象的皮肤。”
美国专利5858001公开了“一种液体药物输送装置......”,“其适于通过限定具有粘合涂层的皮肤接触表面的基座构件粘附到对象的皮肤上。圆筒状药筒用作药物的储存器并且被结合在连接到基座构件的壳体中,使得在使用中药筒的纵向轴线基本平行于皮肤接触表面设置。当壳体相对于基座构件向下卡扣时,与药筒内部连通使用的输送针穿透对象的皮肤。该动作还引起柠檬酸/碳酸氢钠气体发生器的启动,其产生气体以移动药筒内的活塞,从而压缩药物隔室。这种压缩导致塞子被与输送针连通的导管穿透,从而允许药物通过针从隔室射出并进入对象的皮下组织。”
公开号20140163526的美国专利公开了“可以装载有标准型注射筒和/或皮下注射针的自动注射装置。可选地,注射筒可以装载有药物和/或覆盖有无菌针头盖。注射筒可以在无菌状态下装入注射器并且针盖体就位。注射器可以包括例如紧固件(例如粘合基座)。在一些实施例中,紧固件可以帮助用户将注射器长时间稳定地保持在患者的皮肤上。例如,注射器可用于在30秒至180秒时间范围内给予0.5至3.0毫升体积范围的注射。”
另外的背景技术包括专利号为6189292、专利公布号为20130253434、专利公布号为2009/093,792、专利号为7967795的美国专利。
发明内容
示例1.一种药物注射筒,具有带近侧开口的圆筒形膛,所述圆筒形膛具有中心轴线,所述注射筒包括:所述膛的远侧壁,其限定出口,所述出口从所述中心轴线朝向所述远侧壁的第一区域偏置并且从中心轴线远离与第一区域不同的第二区域偏置;以及柱塞密封件,所述柱塞密封件的周部的尺寸和形状被设置成适合所述圆筒形膛,所述柱塞密封件与所述圆筒形膛同轴,所述柱塞密封件具有远侧表面;其中当所述柱塞密封件装配到所述膛中时,所述远侧表面面向所述膛的所述远侧壁的内表面,所述内表面的所述第二区域在平行于圆筒形孔的中心轴线的方向上比所述第一区域在轴向更靠近所述柱塞密封件的所述远侧表面。
示例2.示例1的药物注射筒,其中所述内表面的平均方向相对于所述中心轴线倾斜。
例3.示例2的药物注射筒,其中所述内表面的平均方向相对于所述中心轴线以约1度至约5度范围内的角度倾斜。
例4.示例1-3任一项的药物注射筒,其中所述内表面的所述第二区域轴向更靠近所述柱塞密封件的远侧表面,从而允许在远侧表面接触第一区域之前接触柱塞的远侧表面的至少40%。
示例5.示例1-4任一项的药物注射筒,其中柱塞密封件的远侧表面包括凸起形状。
示例6.示例5的药物注射筒,其中所述内壁包括凹陷形状。
示例7.例6的药物注射筒,其中内壁包括圆锥形形状,并且其中内壁的开口角度没有柱塞密封件的远侧表面的凸起形状的开口角度尖锐。
示例8.例1-7中任一项的药物注射筒,其中内表面不是径向对称的。
示例9.示例1-8中任一项的药物注射筒,其中当所述柱塞密封件与所述膛同轴时,所述内表面的第一区域的平均方向远离所述柱塞密封件的远侧表面的平均方向成角度。
示例10.示例1-8中任一项的药物注射筒,其中当所述柱塞密封件与所述膛同轴时,所述内壁的第二区域的平均方向朝向所述柱塞密封件的远侧表面的平均方向成角度。
示例11.示例1-10中任一项所述的药物注射筒,其中所述轴向更靠近包括所述柱塞的远侧表面的平均外边缘与第二区域的平均外边缘之间的距离小于所述柱塞的远侧表面的平均外边缘与第一区域的平均外边缘之间的距离。
示例12.示例1-11中任一项所述的药物注射筒,其中内表面的第一区域的表面和内表面的第二区域的表面之间的过渡是连续的。
示例13.示例1-12中任一项所述的药物注射筒,其中包括偏置流体出口的内壁的第一区域位于膛的边缘附近,并且第二区域位于膛的相对的边缘附近。
示例14.示例1-13中任一项所述的药物注射筒,其中所述药物注射筒还包括源自所述偏置流体出口的弯曲流体路径。
示例15.一种用于减少药物注射筒中的流体死区的方法,所述药物注射筒具有带有近侧开口和远侧偏置流体出口的圆筒形膛,所述圆筒形膛与柱塞密封件配合,所述方法包括:驱动所述柱塞密封件朝向所述圆筒形膛的远端;在与包括所述偏置流体出口的区域不同的接触区域处使所述柱塞密封件的远侧表面的一部分与所述膛的远端的壁的内表面的一部分接触;以及从接触位置朝向偏置流体出口的位置扩大一定范围的接触,同时沿相对于柱塞的远侧表面的平均方向倾斜的平均方向排出流体。
示例16.例15的方法,其中所述接触包括在作为所述内表面的外围边缘的所述接触区域处初始接触,所述外围边缘与包括所述偏置流体出口的区域不同。
示例17.例15的方法,其中在所述接触区域处的所述接触包括在接触包括偏置流体出口的区域之前接触柱塞的远侧表面的至少40%。
示例18.例15-17中任一项所述的方法,其中所述扩大包括扩大从所述外围边缘通过所述内壁的中心部分并到达包括所述偏置流体出口的区域的接触范围。
示例19.例15-18中任一项所述的方法,其中通过使所述柱塞密封件弹性变形来扩大所述接触范围。
示例20.例15-19中任一项所述的方法,其中扩大所述接触范围导致驱动流体远离所述接触位置朝向所述偏置流体出口的位置。
示例21.例15-20中任一项所述的方法,其中所述方法还包括以范围在约5N和约25N之间的力终止所述柱塞密封件的驱动。
示例22.例21的方法,其中在所述终止之后,所述柱塞密封件和所述内壁之间的流体死区的体积范围在约0.01ml和约0.5ml之间。
除非另外定义,否则本文使用的所有技术和/或科学术语具有与本发明所属领域的普通技术人员通常理解的相同的含义。尽管在本发明的实施例的实践或测试中可以使用与本文所述的方法和材料类似或等同的方法和材料,但是下面描述示例性的方法和/或材料。如果发生冲突,将控制包括定义在内的专利说明。另外,这些材料、方法和实例仅是说明性的,并非意在限制。
附图说明
本文仅通过举例的方式参照附图来描述本发明的一些实施例。现在具体参照附图详细说明,需强调所示出的细节是作为示例并且出于对本发明的实施例的说明性讨论的目的。就此而言,对于本领域技术人员而言,利用附图所作的描述对于可以如何实施本发明的实施例是显而易见的。
在附图中:
图1是示出了根据本发明的一些实施例的具有减小的流体死区的注射筒的示意机构的框图;
图2是示出了根据本发明的一些实施例的用于减少注射筒中的流体死区的方法的流程图;
图3是示出了根据本发明的一些实施例的由图2所示的方法产生的流体动力学的流程图;
图4A-4B是本发明的一些实施例中使用的具有偏心流体出口的注射筒的示意图,其中图4A是透视图,图4B是穿过注射筒的背腹(dorsal-ventral)纵向轴线截取的横截面图;
图5A-5E是示出了显示根据本发明的一些实施例的注射筒的横截面的示意图,该注射筒具有在其远端处偏心流体出口以及远端的凹内壁相对于注射筒的纵向轴线的各种定向,其中图5A示出了具有未修改的内壁的注射筒的概况,图5B示出了图5A中的标记区域的放大部分,图5C示出了倾斜的凹内壁,图5D示出了具有倾斜的腹侧部分的凹内壁,以及图5E示出了具有倾斜的背侧部分的凹内壁;
图6是根据本发明的一些实施例的与柱塞密封件接触的倾斜内壁的横截面的示意图;
图7A-7C是根据本发明的一些实施例的包括在倾斜内壁中的倾斜角度的图示,其中图7A示意性地示出了与注射筒的纵向轴线一起的倾斜内壁的横截面,图7B示出了例示不同倾斜角度之间的连续过渡的极坐标图,以及图7C示出了例示不同倾斜角度之间的阶跃过渡(step transition)的极坐标图;以及
图8是示出根据本发明一些实施例的包括可变形平面柱塞和注射筒的倾斜内壁的实施例的透视图的示意图。
具体实施方式
本发明在其一些实施例中涉及成角度的注射筒,并且更具体地但非排他地涉及具有减小的流体死区的成角度的注射筒。
概述
本发明的一个方面涉及一种不对称注射筒,其具有用于容纳流体并具有减小的流体死区的储存器。在一些实施例中,将柱塞密封件装配到注射筒膛中以将流体从所述膛的近侧部分朝向设置在所述膛的远侧部分中的偏心出口流体路径驱动。在一些实施例中,潜在地减少流体死区,储存器的远侧内壁的形状设置为当被柱塞密封件接触时朝着偏心出口流体路径驱动流体。例如,柱塞密封件可以配置成在接触壁的中央部分之前接触储存器的远侧内壁的周界部分,随后接触包含离开膛的流体路径的壁的相对周界部分。可选地,膨胀的柱塞壁接触件朝着非接触部分排出流体,由此消除朝向偏心出口流体路径的流体。
如本文所使用的,术语死区是指一旦柱塞不再能够朝向注射筒的远端进一步被驱动时,保留在医用注射筒内的流体的体积。通常,流体保留在针内和/或注射筒中心和柱塞之间。相对较高的流体死区的潜在缺点包括药物浪费、和/或不准确的剂量和/或潜在的疾病传播。
在一些实施例中,储存器的远侧壁和/或内部远侧壁向包含针的边缘稍微倾斜。可选地,这可以改善到偏心位置的针中的排放。可替换地或另外地,内部远侧壁稍微朝向柱塞倾斜以产生偏移到流体出口的位置的初始接触位置,潜在地导致流体被从偏移位置朝向出口驱动。
在一些实施例中,包括流体储存器的药筒可以被设计成减少死区。例如,柱塞可以由用户将流体从储存器中驱出。例如,柱塞可以朝着储存器的远侧壁驱动流体。可选地,流体可以穿过远侧壁中的开口到达通向注射筒针的延伸部的流体路径。可选地,柱塞可以被设计成初始接触距开口最远的远侧壁的第一部分,并且在朝向壁被驱动时逐渐增加与远侧壁的接触。例如,当柱塞在首次接触壁之后向远侧运动时,壁的增加表面可能接触柱塞。例如,当接触表面增加时,流体可以沿着远侧壁朝着开口被驱动。
在一些实施例中,柱塞由可选地具有旋转推进机构的发动机驱动。标准柱塞可能被设计成从位于中心的出口排出流体。因此,在具有位于中心的出口的标准注射筒中,由最靠近出口的表面限定的柱塞的远侧表面可能围绕膛的中心轴线径向对称,可选地具有标准凸起形状。在一些实施例中,如本申请中提供的注射筒被配置成允许使用具有径向对称性的标准柱塞进行非同心流体排出。
例如,储存器的远侧内壁可以是圆锥形和/或凹陷的,而柱塞密封件可以是锥形的和/或凸起的,其开口角度比注射筒的远侧内壁的开口角度更尖锐。或者,柱塞的远侧表面基本上是平坦的。可选地,注射器的内部远侧壁可以相对于柱塞密封件和/或膛(bore)的轴线成角度。例如,在流体出口侧与柱塞密封件接触之前,膛的远侧内壁可以成角度以在与出口流体路径相对的侧上接触柱塞密封件,例如通过使相对侧沿着注射筒膛的纵向轴线轴向更靠近柱塞远端面。在一些实施例中,内部远侧壁通过使其纵向轴线相对于柱塞的远侧表面的纵向轴线成角度而成角度。例如,内壁的纵向轴线可以以约0.5°至约2°,和/或约2°至约5°,和/或约5°至约10°,和/或更小、更大或中等的任何角度范围成角度。
例如,在大约0-5N和/或大约10-15N之间和/或大约15-25N之间范围的力的作用下,在柱塞朝向圆筒远端壁的行程结束时,柱塞与圆筒远侧壁之间的死区可以在约0.01至0.05和/或约0.05至0.1和/或约0.1至0.5ml之间的范围内。任选地,在延伸部的远侧区段中的储存器与流体路径的出口开口之间的流体路径的体积可以是小的。例如,从储存器到延伸部的开口的流体路径的内部容积可以在0至0.01和/或0.01至0.03和/或0.03至0.06和/或0.06至0.1和/或0.1至0.5ml之间的范围。
在一些实施例中,注射筒膛的内部远侧壁是对称的,可选地围绕圆筒形膛的中心轴线。可选地或另外地,注射筒膛的内部远侧壁不是对称的。可选地,内部远侧壁的仅一部分是成角度的。例如,在一些实施例中,包括流体出口的周部侧从柱塞的远侧表面成角度地倾斜,可选地,当相对的周部侧与柱塞面的轮廓匹配时。可选地,相对的周部侧朝向柱塞面成角度,可选地,当包括流体出口的周部侧与柱塞面的轮廓匹配时。
在一些实施例中,内壁的一部分和/或区域和/或侧面的角度由该区域的平均方向及其相对于膛的中心轴线的倾角和/或倾斜限定。在具有同心出口的典型注射筒中,膛的内部远侧壁的平均方向垂直于膛的中心轴线。在一些实施例中,内部远侧壁倾斜成使得整个内部远侧壁的平均方向相对于中心轴线限定大于90°的角度。可选地,内壁的至少一个区域被成形为基本上配合柱塞远侧表面,而内壁的至少一个不同区域与柱塞的远侧表面成角度远离或朝向柱塞的远侧表面。在一些实施例中,内壁的至少一个区域相对于柱塞的倾斜导致内壁的区域更接近柱塞远侧表面。如本文所使用的,内壁和柱塞有多近,由远侧内壁(或其一部分)的平均外边缘与柱塞远侧表面的平均外边缘之间的距离限定。在一些实施例中,接触区域更靠近柱塞的远侧表面,其被提供为比流体出口区域更近0.05-0.1mm、0.1-0.3mm或0.2-0.4mm的距离或者更大、更小或中间的任何范围。
在一些实施例中,第一区域包括流体出口,并且不同于第一区域的第二区域的形状设置为首先接触柱塞。在一些实施例中,内表面的第二区域轴向更靠近柱塞密封件的远侧表面,使得其允许在远侧表面接触第一区域之前接触柱塞的远侧表面的至少40%。或者,第二区域的接近允许与柱塞密封件的远侧表面接触至少30%、或至少20%、或至少50%。
在一些实施例中,内表面的第二区域包括内表面的80%,不具有流体出口。或者,第二区域包括内表面的至少90%、和/或至少95%、和/或至少99%。在一些实施例中,第一区域包括含有流体出口的连接区域。可选地,第一区域小于远侧表面的2%、和/或小于5%、和/或小于10%。
可选地或另外地,柱塞的远侧表面在以将第一区域与第二区域分开的方式密封至内表面之前从第二区域排出流体。在一些实施例中,提供了内壁的其他不对称配置。例如,在一些实施例中,内壁具有非直角椎体的形状,和/或具有由椎体形结构的组合制成的部分。例如,内壁的第一侧的形状可选地可设置成具有第一顶角的第一锥体的一部分,并且内壁的第二侧的形状可选地可设置成具有第二顶角的第二锥体的一部分。可选地,第一顶角和第二顶角不相同。可选地,由第一锥体和第二锥体的基座限定的直径不同。在一些实施例中,在与流体出口相对的一侧处提供更尖锐的顶角,可能使该侧倾斜以使在该侧具有不太尖锐的顶角之前与该柱塞面接触。在一些实施例中,第一锥体壁和第二锥体壁之间的过渡(transition)是连续的。可选地或另外地,该过渡基本上是一个阶梯过渡。
柱塞密封件可选地具有圆形横截面。例如,柱塞密封件可以由涂覆有PTFE层的氯丁基橡胶和/或溴化丁基橡胶或EPDM或其他合适的密封材料和/或适用于药品和注射的筒材料在产品保质期内使用的材料制成。在一些实施例中,柱塞由基本上可变形的材料制成,被配置成当被压在膛的远侧内壁上并且与其表面匹配时变形。
在一些实施例中,通过模制和/或增加一个层到内部远侧壁的偏移到流体出口的区域来提供与柱塞远侧表面不对称的接触表面。可选地,增加层以形成轴向比包括流体出口的区域更靠近的接触区域。在一些实施例中,增加的层深度在0.05-0.1mm、0.1-0.3mm或0.2-0.4mm的范围内或者更大、更小或中间的任何范围内。可选地,圆筒形注射筒包括右圆筒形主体。或者,注射筒包括非直角圆筒形状。可选地,柱塞密封件具有不均匀的面。例如,柱塞可以不具有围绕其中心轴线的对称表面,例如,柱塞远侧表面的一个区域可以比另一个区域轴向更靠近远侧壁。可能地,在包括不均匀柱塞表面的实施例中,当被推动到远侧壁上时柱塞相对于注射筒不旋转。
在一些实施例中,用于减少流体死区的附加措施包括细流体出口路径。可选地或另外地,通过提供具有相对较小体积的收集器(collect)来减少流体死区,该收集器主要用于在针路径和储存器之间流体连接。
在一些实施例中,当批量生产本文提供的注射筒时,在代表性样品中,至少99%的注射筒和/或至少97%和/或至少90%的注射筒,第二接触区域将在包括流体出口的第一区域之前接触。在一些实施例中,代表性样品包含至少50个注射筒、和/或至少100个注射筒、和/或至少500个注射筒、和/或至少1000个注射筒。
在详细解释本发明的至少一个实施例之前,应当理解的是,本发明在其应用中不一定限于后文描述和/或附图和或示例中阐述的部件的的构造和布置和/或方法的细节。本发明能够具有其他实施例或以各种方式实践或执行。
1.用于减少流体死区的高级机构
现在参照附图,图1示出了说明用于减少注射筒中的流体死区的总体示意性机构的框图,根据本发明的一些实施例,该注射筒具有配合柱塞120的圆筒形膛101并且具有开口的近端107和在其远端105处的偏心流体出口130。
在一些实施例中,通过提供远侧内壁112来减少死区,所述远侧内壁配置成在接触流体出口的位置之前在与流体出口位置偏移的接触位置处与柱塞120的面接触。首先通过接触偏移位置,流体可能被驱向内壁和柱塞之间的未接触空间,非接触空间包括流体出口。
在一些实施例中,内壁112的第一区域114包括流体出口,并且内壁112的第二区域116配置成在第一区域之前接触柱塞120的表面。例如,在一些实施例中第二区域116朝向柱塞120的表面成角度。可选地或另外地,第一区域114远离柱塞120的表面成角度。可选地或另外地,内壁112成角度,使得由内壁横截面限定的平均方向相对于柱塞120面的横截面的平均方向成角度。
2.用于减少死区的示例性方法
现在参考图2,示出了例示根据本发明的一些实施例的用于减少具有偏心流体出口的注射筒中的流体死区的方法的流程图。为了将流体从药筒通过流体出口排出,柱塞密封件被驱动202朝向包含出口的药筒的远侧部分。
减少药筒内剩余流体的一种方法是从不同于包括流体出口的区域的区域收集流体。因此,在一些实施例中,柱塞密封件的远侧表面与药筒的远侧壁的内表面的区域接触,该区域不同于包括偏心出口的区域204。可选地,内表面的尺寸和形状设置为在与出口位置不同的区域更靠近柱塞密封件远侧表面。
在一些实施例中,通过将柱塞沿着出口的方向驱动来扩大柱塞表面与内壁的朝向出口的接触范围206。在一些实施例中,为了接触增加的内壁部分,柱塞相对于远侧壁的内表面弹性变形。
在一些实施例中,出口区域的不同区域位于出口的相对部分,例如,如果出口位于限定为药筒的背侧部分的边缘附近,则不同区域可以在药筒的腹侧部分的范围内。可选地或另外地,不同区域可以比出口更靠近药筒边缘。例如,如果出口位于药筒的背侧部分附近,出口和背侧边缘之间的区域可以被认为是不同的,并且在一些实施例中,该不同区域的形状可设置成比出口区域更靠近柱塞。可选地,在柱塞接触包括偏置流体出口的区域之前,不同区域接触柱塞的远侧表面的至少20%、和/或至少30%、和/或至少40%、和/或至少50%。
3.由减少死区配置导致的潜在流体路径
现在参考图3,其例示了根据本发明的一些实施例的由图1中示出的配置和/或图2中示例的方法导致的可能的流体动力学路径。
一旦柱塞被朝向药筒的远侧部分驱动302,则包含在药筒中的流体朝向药筒远侧壁被排出304,可选地通过药筒的偏心出口排出。在一些实施例中,只要柱塞被朝向远侧边缘驱动,包括当柱塞的远侧表面最初在不同于出口的区域的区域处接触药筒远侧壁的内表面时,流体就从药筒中排出306。
在一些实施例中,当流体被驱动从初始接触位置离开并朝向出口位置时,流体继续在柱塞表面与远侧壁的内表面初始接触之后排出308,可选地通过使柱塞变形以扩大其接触范围。在一些实施例中,在柱塞与远侧壁的一部分初始接触更靠近它时,在远侧壁的方向上施加力时,柱塞变形。由于闭合部分的机械障碍,柱塞的接触部分不能再前进,但是在一些实施例中,柱塞远侧表面在被强压到远侧壁上时弹性变形,导致接触范围增加。
在一些实施例中,远侧内壁的平均方向导致流体沿着该方向排出,该方向相对于柱塞的远侧表面的平均方向倾斜。
4.具有偏心流体出口的药物输送装置的示例性配置和尺寸
现在参考图4,其示意性地示出了例如在药物输送装置中有用并且在本发明的一些实施例中使用的不对称注射器的示例。
本文提供了例如注射筒409的药物输送药筒的典型和/或示例性尺寸。在一些实施例中,储存器和/或空腔432(例如在注射筒409中)的有效载荷可以包括例如在0.5和2ml之间和/或在2和7ml之间和/或在7和6ml之间和/或在7和10ml之间的药物和/或安慰剂和/或任何生物活性和/或非生物活性物质。在一些实施例中,注射器可以将整个有效载荷作为单剂量卸载。药物输送装置可以包括例如贴片注射器和/或内部供电的驱动器以驱动柱塞和/或卸载有效载荷。
用于该申请,内部供电的注射器驱动器可以被限定为由至少暂时存储在注射器内的能量驱动的驱动机构。电力可以存储在电源中,例如作为化学能(例如产生膨胀气体和/或电池的化学制品)和/或机械能(例如存储在弹性构件和/或弹簧和/或加压气体中)。例如,驱动器可以被设计成在20至120秒和/或120至600秒和/或600秒至1小时之间和/或1小时至一天和/或更长的时间段内卸载有效载荷。
一般来说,卸载可能由驱动器驱动。内部供电的驱动器可以由各种机构供电,包括例如所讨论的马达,包括例如DC马达、致动器、无刷马达和/或包括例如伸缩组件和/或螺纹元件的变速器、和/或齿轮和/或联轴器和/或弹性机构(例如弹簧和/或橡胶带)和/或膨胀气体和/或液压致动器。
根据本发明的一些实施例的药物输送装置可以包括所讨论的储存器部分。例如,储存器可以包括药物容器和/或注射筒。可选地,可以使用标准设备和/或在无菌室给注射筒预装载药物。预装载注射筒可以可选地包括近侧开口。柱塞可以可选地密封近侧开口和/或保护注射筒的内容物的无菌性。通常为空心的无菌针头可以可选地连接到注射筒膛。例如,针的中空部可以与膛的内部流体连通。针可以可选地刚性地附接到膛的远端处的延伸部。
在一些实施例中,柱塞可以沿膛的内部轴向滑动以卸载药物有效载荷。例如,药物可以通过中空针头卸载。针的突出尖端可以与膛的轴线成一定角度定向。
任选地,注射药物所需的力(例如在注射筒柱塞上的力)可以在例如5至60N之间。例如,注射药物所需的力取决于注射速率和/或药物的粘度和/或注射筒几何形状和/或针的尺寸。
例如,药物输送装置可以包括自动注射器。自动注射器可以通过用足够的力手动推动以插入针来启动。该装置然后可以施加注射力以注射药物。一旦全部药物被注射和/或当存在阻碍和/或闭塞时,注射力可能上升,直至其通过阈值,从而触发针头保护和/或结束注射。
例如,如果发生闭塞和/或输送结束,设备产生的线性力可能会增加到最高60N的水平。针防护机构(例如针缩回机构)可能对力敏感。例如,该机构可以包括卡扣,该卡扣在70N时使针返回到缩回位置。
在一些实施例中,注射药物和/或触发针的安全保护的应力可以包括扭矩。例如,药物的注射可能由柱塞驱动。柱塞可以可选地由螺纹组件例如螺纹螺钉和/或齿和/或伸缩组件驱动。可选地,齿和/或相关联的螺钉的螺距可以在例如0.5和2mm之间的范围内。螺钉的直径可以在例如2.5和15mm之间的范围内。用于动力注射的扭矩可以在例如0.2和1.0N*cm之间的范围内。在注射期间,柱塞的线性运动可以在例如10-50mm之间的范围内。柱塞的运动的长度可以例如随着待注射的药物的体积而变化,其可以例如在0.5至3ml之间。
在一些实施例中,储存器可具有例如在20和72之间和/或72和78mm和/或78和80mm和/或80和200mm范围内的长度。在一些实施例中,储存器的内部圆筒形空间可具有例如在1和3mm之间和/或3和10和/或10和15mm和/或15和25mm和/或25和50mm之间的平均宽度。可选地,储存器可以具有圆形横截面,使得宽度是圆的直径。在一些实施例中,延伸部可具有直线端部,其具有例如在1和3mm或3和7mm或7和8或8和10mm或10和15mm或15和50mm之间的长度。在一些实施例中,针的暴露的笔直部分可具有例如1至5mm或5至7mm或7至10mm或10至20mm之间的长度。
在一些实施例中,延伸部和储存器空腔之间的流体路径可以包括27号针或范围在25至30号之间的针或范围在20至25号之间的针或范围在30至32号之间的针。在一些实施例中,从延伸部突出的针可以包括27号针或范围在25至30号之间的针或范围在20至25号之间的针或范围在30至32号之间的针。
现在参考图4B,其示意性地示出了根据本发明的一些实施例的设计用于减少死区的膛的横截面。在一些实施例中,连接在膛442的空腔432和毂(hub)436之间的流体路径450可以穿过和/或被模铸到注射筒409中。可选地(例如,如图4B所示),金属针452形成流体路径450的一部分。可选地,通过在针452内部具有整个路径来减少流体路径450中的死区(减少塑料模具中的死区)。例如,针452的嵌入部分453形成至突出部分451的弯曲流体路径450。突出部分451可选地直接伸出毂436,与空腔的轴线458和/或膛442的轴线458基本成直角。可选地针体452的突出端为倾斜和/或削尖以便于穿过对象的皮肤插入。
在一些实施例中,减小将针452的端部约束在空腔432内的端部安装件的尺寸以减小模铸后留下的死区。可选地,端部安装件可以包括销和/或收集器(collect)。例如,收集器可具有握住针452的端部的凹面和/或圆锥形内表面。可选地或附加地,销可以具有能装入到针452的中空部中的凸面和/或圆锥形表面和/或在插入时自对准。例如,销可以包括能装入到针452中的内凸部和/或定位针体452的外凹部。在模铸之前,销的外凹部可定位针452以将销的内凸部插入针452的中空部中。然后,外凹部可在成型之前缩回。可选地,在模制期间,只有销的内部保留在模具中。在模铸之后,可选地移除内销,当药物从注射器排出时留下减小的死区。
5.示例性的远侧内壁配置
图5A-5E举例说明了根据本发明的一些实施例的用于远侧内壁的可能配置,从而导致柱塞-壁接口可能地减少流体死区。
为了说明目的和描绘有用的轴线定义,图5A和5B示意性地示出了具有膛的药物注射筒,该膛具有形状被设置成配合柱塞远侧表面的内部远侧壁,两者均具有基本上非倾斜和对齐的平均方向,其中图5B是图5A中的标记圆圈区域的放大图。
图5A示意性地示出了上述注射筒的一个实例的横截面的侧视图。在一些实施例中,注射筒包括配合柱塞密封件470的圆筒形膛442。可选地,膛具有开口的近端440。在一些实施例中,在其远端438处,膛442包括具有内表面488的壁,可选地,内表面488具有与远端438的外表面不同的轮廓和/或横截面。在一些实施例中,膛442包括偏心流体出口456,可选地流体地连接储存器432与路径450,路径450可选地相对于膛442的中心轴线458弯曲。在一些实施例中,路径450弯曲使得针尖451指向膛442的腹侧439b。可选地,为了允许用于弯曲路径450的尽可能多的空间,偏心流体出口被偏置到膛442的背侧。
在一些实施例中,柱塞470包括具有接口的远侧表面475,所述接口的尺寸和形状设置为接触内表面488的至少一部分。可选地,内表面488的形状设置为使得初始柱塞内表面接触位置偏移到流体出口的位置。在一些实施例中,远侧表面475是凸起的。在一些实施例中,内表面488是凹入的。在一些实施例中,由内表面488限定的打开角度与由远侧表面475限定的打开角度基本相同。
下面参考图5B-5E描述内表面488关于其与远侧表面475匹配的各种区域,其具有各种倾斜角度和/或凹陷和/或平均方向。
图5B示出了不成角度的示例,示出了图5A中标记的圆形区域的放大图。示例内表面488的两个不同区域484和482的平均方向584和582。在图5B的不成角度示例中,内表面488具有与柱塞远侧表面475的平均方向一致的平均方向。更具体地说,当柱塞远侧表面475围绕中心轴线458对称时,在该示例中,背侧区域482和腹侧区域484具有相同的平均方向584和582,这些平均方向584和582也与远侧表面475的背侧部分和腹侧部分的平均方向一致。
图5C示出了背侧区域482和腹侧区域484的倾斜。所示出的是背侧区域482相对于原始平均方向582以角度A倾斜。还示出腹侧区域484相对于原始平均方向584以角度B倾斜。在一些实施例中,包括出口的区域,例如在该实施例中区域482,远离柱塞倾斜,而与包括出口的区域不同的区域,例如在该实施例中区域484,朝向柱塞倾斜。可选地,角度A和B是相同的。或者,角度A和B以不同程度倾斜。在一些实施例中,区域482和/或区域484具有弯曲的背腹横截面。优选地但不是强制的,区域482和/或484的曲线是凹的,从柱塞弯曲离开,可能地地防止更多的死区。
图5D示出了仅腹侧区域484以角度B倾斜。在所示实施例中,区域484不同于包括出口456的区域。通常期望流体将从围绕出口484的区域排出,并且因此在一些实施例中,区域484朝向柱塞表面475倾斜,可能地首先接触其表面并且朝向出口区域482驱动流体离开。
图5E示出了仅背侧区域482以角度A倾斜。在所示实施例中,区域482包括出口456。因为通常期望流体将从围绕出口484的区域排出,所以在该实施例中,区域482远离柱塞表面475倾斜,导致区域484更靠近柱塞表面475并且可能首先与柱塞表面475接触。
6.减少死区的柱塞接口
图6是根据本发明的一些实施例的注射筒的远侧部分609的横截面图,其具有成角度的内部远侧壁678和安装在圆筒形空腔432上的偏离中心的成角度的毂436。例如,流体路径可以在偏心出口456的位置处连接到膛442的空腔432。在一些实施例中,柱塞密封件670的远侧表面可以具有凸起的基本圆锥形状和开口角度668。在一些实施例中,圆筒形空腔432的远侧壁的内表面678可以具有基本凹入的圆锥形状和开口角度666。可选地,柱塞密封件的远侧表面的开口角度668可以比圆筒形空腔432的内部远侧壁678的开口角度666更尖锐。可选地,圆筒形空腔432的内部远侧壁678可以相对于柱塞密封件670的远侧表面成角度,例如,内部远侧壁678可以具有偏移到由柱塞密封件670的远侧表面限定的平均方向的平均方向。为了更好地示出模制特征,形成流体路径450的边界的可选针452未在图6中示出。
在一些实施例中,特征可被配置成避免流体被捕获在远侧柱塞密封件670和圆筒形空腔432的内部远侧壁678之间的死区中。例如,柱塞密封件670的远侧表面的形状和/或空腔432的远侧内壁678的形状可配置成当柱塞密封件670接近空腔432的内部远侧壁时将流体推向流体路径450的开口。例如,在一些实施例中,在流体路径450在空腔432的外部边缘附近连接到空腔432的情况下,柱塞密封件的远侧表面的开口角度668可以比圆筒形空腔432的内部远侧壁678的开口角度666更尖锐。例如,柱塞密封件670的远侧表面的开口角度可以在小于0至1度和/或小于1至3度和/或小于1至5度和/或小于5至10度和/或比空腔432的远侧壁678的开口角度小10至30度。可选地或另外地,在流体路径450在空腔432的轴线458附近连接到空腔432(例如如图5所示)的一些实施例中,柱塞密封件的远侧表面的开口角度668可以不如圆筒形空腔432的内部远侧壁678的开口角度666那样尖锐。
在一些实施例中,在流体路径450连接到空腔432的外边缘附近的空腔432的情况下,连接到流体路径450的圆筒形空腔432的内部远侧壁678可以成角度远离远侧柱塞密封件670。例如,柱塞密封件670和/或其远侧表面可以与圆筒形空腔432的轴线458对齐,而锥形远侧内壁678的轴线680处于轴线458和/或柱塞密封件670的轴线和/或柱塞密封件670的锥形面的轴线的0至0.1度之间的角度和/或0.1至1度之间和/或1至3度之间和/或3至10度之间和/或10至30度之间的角度。可选地或另外地,远侧内壁678可以不是正圆锥形和/或可以不是圆锥形和/或可以不是对称的。例如,流体路径450可以连接到中心和外边缘之间的内部远侧壁678和/或连接到路径450的内部远端壁678的部分可以相对于内部远侧壁678的其余部分略微向远侧凹入,导致平均方向582相对于由柱塞密封件670的远侧表面的外部限定的轴线671倾斜角度α。在一些实施例中,α具有0至0.1度和/或0.1至1度和/或1至3度和/或3至10度和/或10至30度之间的范围。例如,在一些实施例中,流体路径450可以在空腔432的背侧439a附近连接。然后,内部远侧壁678的轴线可选地相对于轴线458和/或柱塞密封件670的锥形面的轴线以正角度倾斜。
在一些实施例中,当插入空腔432中时,柱塞密封件670可以围绕轴线458基本对称。例如,柱塞密封件670可以具有与空腔432的内侧壁接触的密封表面672和/或稳定表面674。可选地,柱塞密封件670可以包括柱塞驱动器安装件676。柱塞驱动器安装件676可选地与空腔432同轴。
在一些实施例中,对于偏离中心的流体路径,柱塞密封件670的远侧表面可以具有凹陷的基本圆锥形状,并且圆柱形空腔432的内部远侧壁678可以具有基本上凸起的圆锥形状。可选地,柱塞密封件的远侧表面的开口角度可以不如圆筒形空腔432的内部远侧壁678的开口角度那样尖锐。
7.可变角度的壁
现在参考图7,其示出了根据本发明的一些实施例的相对于注射筒膛的中心纵向轴线具有可变角度的壁。
图7A示出了根据本发明的一些实施例的内表面488,其具有背侧439a和腹侧439b并且具有围绕轴线458限定可变角度的壁。在一些实施例中,限定为包括出口456的区域的所述内表面的第一区域482的形状设置成具有顶角2β的第一锥体的一部分,以及限定为与出口区域不同的区域的所述内表面的第二区域484的形状设定成具有顶角2α的第二锥体的一部分。在一些实施例中,中心轴线458分割每个顶点,使得区域482的平均方向与轴线458之间的角度处于角度β,并且区域484的平均方向与轴线458之间的角度处于角度α。在一些实施例中,第二锥体具有比第一锥体更尖锐的顶角,即α<β。
图7B和图7C示出极坐标图,其示出了在所述内表面的第一区域482和所述内表面的第二区域484之间发现的过渡部702a和702b,其中点C对应于背侧439a以及点G对应于腹侧439b。在一些实施例中,区域482与区域484之间的过渡是连续的,如图7B所示。可选地或另外地,区域482和区域484之间的过渡是不连续的,并且可选地具有基本上是阶梯图(stepgraph)的形状。在一些实施例中,一侧(例如A)中的区域482与区域484之间的过渡与另一侧(例如B)中的过渡相同,至少在背腹线上保持对称性。或者,每一侧的过渡都不相同。
8.平面柱塞密封件
图8示意性地说明了根据本发明的一些实施例的具有柱塞密封件870的药物注射筒800,柱塞密封件870具有平坦远侧表面875。在一些实施例中,注射筒800包括用于容纳流体的药筒842,其具有远端838,终止于包括背侧882和腹侧884的内部远侧表面888。在一些实施例中,靠近背侧882的流体出口856位于相对于中心轴线858偏心位置。可选地,流体通过出口856排出并且通过流体路径850出去。
在一些实施例中,为了朝向出口856驱动流体,同时具有减少的残留在药筒842中的流体,并且特别在内表面888和柱塞表面875之间的空间中,表面888的腹侧部分884朝向表面875倾斜。可选地或另外地,背侧882远离表面875倾斜。倾斜导致内表面888的平均方向982偏移到柱塞表面875的平均方向887。
9.概括
可以预料,在从本申请成为专利期间,将开发许多相关的注射筒装置,术语注射筒和/或药筒的范围旨在预先包括所有这些新技术。
如本文所用,术语“约”是指±25%。
术语“包括”、“包括有”、“包含”、“包含于”、“具有”及其结合意味着“包括但不限于”。
术语“由...组成”表示“包括并限于”。
术语“基本上由...组成”是指组合物、方法或结构可以包括附加的成分、步骤和/或部分,但仅指附加成分、步骤和/或部分不会实质上改变要求保护的组合物、方法或结构的基本特征和新颖特征。
如本文所用,除非上下文另外明确指出,否则单数形式“一”,“一个”和“该”包括复数指代。
贯穿本申请,本发明的各种实施例可以以范围格式呈现。应该理解的是,范围形式的描述仅仅是为了方便和简洁,并且不应该被解释为对本发明范围的不灵活的限制。因此,范围的描述应被视为具体公开了所有可能的子范围以及该范围内的单个数值。例如,从1到6的范围的描述应该被认为具有特定公开的子范围,例如从1到3、1到4、1到5、2到4、2到6、3至6等,以及该范围内的个别数字,例如1、2、3、4、5和6。无论范围的宽度如何,这都适用。
无论何时在此指出数字范围,其意图包括在所指示的范围内的任何引用的数字(分数或整数)。第一指示数字和第二指示数字之间的“范围/范围之间”和“范围/范围从”第一指示数字“到”第二指示数字在本文中可互换使用,并且意在包括第一和第二指示数字以及它们之间的所有分数和整数数字。
如本文所使用的,术语“方法”是指用于完成给定任务的方式、手段、技术和程序,包括但不限于由化学、药理学、生物学、生物化学和医学领域的从业人员已知或易于从已知方式、手段、技术和程序开发的那些方式、手段、技术和程序。
应该认识到,为了清楚起见,在单独实施例的上下文中描述的本发明的某些特征也可以在单个实施例中组合提供。相反地,为了简洁起见,在单个实施例的上下文中描述的本发明的各种特征也可以单独地或以任何合适的子组合或者在本发明的任何其他描述的实施例中合适地提供。除非实施例在没有那些元件的情况下不起作用,否则在各种实施例的上下文中描述的某些特征不被认为是那些实施例的基本特征。
虽然已经结合其具体实施例描述了本发明,但对于本领域技术人员而言,许多替代、修改和变化将是显而易见的。因此,旨在涵盖落入所附权利要求的精神和广泛范围内的所有这些替代、修改和变化。
本说明书中提及的所有出版物、专利和专利申请在此通过引用整体并入本说明书,其程度如同每个单独的出版物、专利或专利申请被具体和单独地指出通过引用并入本文。另外,本申请中任何参考文献的引用或标识不应被解释为承认这种参考文献可作为本发明的现有技术。在使用章节标题的范围内,不应将其解释为限制。

Claims (18)

1.一种药物注射筒,其特征在于,所述药物注射筒包括:
具有近侧开口的圆筒形膛,具有内表面的远侧壁以及中心轴线,所述内表面具有第一区域和不同于所述第一区域的第二区域,所述第一区域限定了所述内表面的整个背侧,所述第二区域限定了所述内表面的整个腹侧,所述圆筒形膛的所述远侧壁限定出口,所述出口从所述中心轴线朝向所述第一区域偏置并且远离所述第二区域被偏置;以及
柱塞密封件,所述柱塞密封件具有尺寸和形状设置成配合在所述圆筒形膛中的周部,所述柱塞密封件与所述圆筒形膛同轴,所述柱塞密封件具有远侧表面;
其中所述内表面不是径向对称的,包括所述出口的所述内表面的所述第一区域位于所述膛的边缘附近,并且所述第二区域位于所述膛的相对的边缘附近,
其中当所述柱塞密封件装配到所述圆筒形膛中时,所述远侧表面面向所述圆筒形膛的所述远侧壁的所述内表面,所述内表面的所述第二区域在平行于所述圆筒形膛的所述中心轴线的方向上比所述第一区域轴向更靠近所述柱塞密封件的所述远侧表面,从而在所述远侧表面接触所述第一区域之前允许所述柱塞密封件的所述远侧表面在初始接触位置接触所述第二区域,从而将流体从所述初始接触位置驱至所述出口,并且
其中所述柱塞密封件被配置为弹性变形,以从所述第二区域向所述第一区域扩展接触范围。
2.根据权利要求1所述的药物注射筒,其特征在于,所述内表面的平均方向相对于所述中心轴线倾斜。
3.根据权利要求2所述的药物注射筒,其特征在于,所述内表面的所述平均方向相对于所述中心轴线以1度至5度范围内的角度倾斜。
4.根据权利要求1-3任一项所述的药物注射筒,其特征在于,所述柱塞密封件的所述远侧表面包括凸起形状。
5.根据权利要求4所述的药物注射筒,其特征在于,所述内表面包括凹陷形状。
6.根据权利要求5所述的药物注射筒,其特征在于,所述内表面包括圆锥形形状,并且其中所述内表面的开口角度没有所述柱塞密封件的所述远侧表面的所述凸起形状的开口角度尖锐。
7.根据权利要求1-3中任一项所述的药物注射筒,其特征在于,当所述柱塞密封件与所述膛同轴时,所述内表面的所述第一区域的平均方向远离所述柱塞密封件的所述远侧表面的平均方向成角度。
8.根据权利要求1-3中任一项所述的药物注射筒,其特征在于,当所述柱塞密封件与所述膛同轴时,所述内表面的所述第二区域的平均方向朝向所述柱塞密封件的所述远侧表面的平均方向成角度。
9.根据权利要求1-3中任一项所述的药物注射筒,其特征在于,所述柱塞密封件的所述远侧表面的平均外边缘与所述第二区域的平均外边缘之间的距离小于所述柱塞密封件的所述远侧表面的平均外边缘与所述第一区域的平均外边缘之间的距离。
10.根据权利要求1-3中任一项所述的药物注射筒,其特征在于,所述内表面的所述第一区域的表面和所述内表面的所述第二区域的表面之间的过渡是连续的。
11.根据权利要求1-3中任一项所述的药物注射筒,其特征在于,所述药物注射筒还包括源自所述出口的弯曲流体路径。
12.一种用于非治疗目的的减小药物注射筒中的流体死区的方法,其特征在于,所述药物注射筒为根据权利要求1所述的药物注射筒,所述方法包括:
朝向所述圆筒形膛的远端驱动所述柱塞密封件;
使所述柱塞密封件的远侧表面的一部分与所述圆筒形膛的所述远端的壁的内表面的一部分在与包括所述出口的区域不同的接触区域接触;以及
从所述接触位置朝向所述出口的位置扩大接触区域,同时沿平均方向排出流体,所述平均方向相对于柱塞密封件的所述远侧表面的平均方向倾斜,
其中在所述接触区域的所述接触包括在接触包括所述出口的所述区域之前接触所述柱塞密封件的所述远侧表面。
13.根据权利要求12所述的方法,其特征在于,所述接触包括在作为所述内表面的外周边缘的所述接触区域处初始接触,所述外周边缘与包括所述出口的区域不同。
14.根据权利要求13所述的方法,其特征在于,所述扩大包括扩大从所述外周边缘通过所述内表面的中心部分并到达包括所述出口的区域的接触范围。
15.根据权利要求12-13中任一项所述的方法,其特征在于,通过使所述柱塞密封件弹性变形来扩大所述接触范围。
16.根据权利要求12-13中任一项所述的方法,其特征在于,扩大所述接触范围导致驱动流体朝向所述出口的位置远离所述接触位置。
17.根据权利要求12-13中任一项所述的方法,其特征在于,所述方法还包括以范围在5N和25N之间的力终止所述柱塞密封件的驱动。
18.根据权利要求17所述的方法,其特征在于,在所述终止之后,所述柱塞密封件和内壁之间的流体死区的体积范围在0.01ml和0.5ml之间。
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US15/269,248 US10086145B2 (en) 2015-09-22 2016-09-19 Rotation resistant friction adapter for plunger driver of drug delivery device
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